[Federal Register Volume 72, Number 69 (Wednesday, April 11, 2007)]
[Rules and Regulations]
[Pages 18118-18119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6828]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Mupirocin 
Ointment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by Altana, Inc. The ANADA provides for 
veterinary prescription use of mupirocin ointment for the treatment of 
bacterial skin infections in dogs.

DATES: This rule is effective April 11, 2007.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
<a href="/cdn-cgi/l/email-protection#80eaefe8eeaee8e1f2f3e8ede1eec0e6e4e1aee8e8f3aee7eff6"><span class="__cf_email__" data-cfemail="29434641470741485b5a41444847694f4d480741415a074e465f">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Altana, Inc., 60 Baylis Rd., Melville, NY 
11747, filed ANADA 200-418 that provides for veterinary prescription 
use of MURICIN (mupirocin) Ointment 2% for the treatment of bacterial 
skin infections in dogs. Altana, Inc.'s MURICIN Ointment 2% is approved 
as a generic copy of Pfizer, Inc.'s BACTODERM Ointment approved under 
new animal drug application (NADA) 140-839. The ANADA is approved as of 
March 8, 2007, and the regulations are amended in 21 CFR 524.1465 to 
reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because

[[Page 18119]]

it is a rule of ``particular applicability.'' Therefore, it is not 
subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 524

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. Revise Sec.  524.1465 to read as follows:


Sec.  524.1465  Mupirocin.

    (a) Specifications. Each gram of ointment contains 20 milligrams 
mupirocin.
    (b) Sponsors. See Nos. 000069 and 025463 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in dogs--(1) Amount. Apply twice daily. 
Treatment should not exceed 30 days.
    (2) Indications for use. For the topical treatment of bacterial 
infections of the skin, including superficial pyoderma, caused by 
susceptible strains of Staphylococcus aureus and S. intermedius.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: March 30, 2007.
Bernadette A. Dunham,
Acting Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-6828 Filed 4-10-07; 8:45 am]
BILLING CODE 4160-01-S


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>